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RYGB innovation

GaBP band significantly improves Roux-en-Y

Bariatrec's GaBP ring, which controls the reservoir size in a Roux-en-Y bypass, was used for the study.
Two year study: adding a GaBP Ring to Roux-en-Y gastric bypass leads to significant improvement in EWL
Modified procedure leads to better resolution of hypertension and cardiovascular risk
New device-associated complications offset by fewer incidents of malnutrition

Banded Roux-en-Y gastric bypass leads to significant improvements in weight loss and resolution of comorbidities compared with conventional Roux-en-Y bypass, according to the results of a two-year, multi-centre trial presented at IFSO 2012.

The study, which involved 143 patients, found that using BariaTec Corporation’s GaBP Ring to control the reservoir size in a gastric bypass led to increased excess weight loss, better resolution of hypertension, improved triglyceride levels, and comparable resolution of diabetic factors two years post-operation.

The study, which was presented at the conference by Dr Konrad Karcz, was designed to find if the use of the GaBP ring could reduce the dilation of the gastro-entero anastomosis and adjacent small bowel, and whether this led to post-operative weight loss and weight maintenance.

Patients were recruited at thirteen medical centres in Europe and the Middle East, with operations performed by Konrad Karcz, as well as Luc Lemmens (Belgium), Walid Bukhari (Saudi Arabia), Rui Ribeiro (Portugal), Mario Nora (Portugal), Tomasz Szewczyk (Poland) Jan W.M. Greve (Netherlands), Karl Miller (Austria), Jodok Grüneberger (Germany), and Simon Küsters (Germany).

Results

The trial compared 60 patients receiving conventional laparoscopic Roux-en-Y gastric bypass with 83 patients who received a banded Roux-en-Y bypass.

At two years, the banded patients had achieved a mean excess weight loss of 90.01%, compared with 72.94% for the conventional patients.

While the two groups had comparable mean pre-operative BMI, at 44.91 for the conventional patients and 44.74 for the banded patients, after two years, the banded patients’ mean BMI had dropped to 26.14, compared with 29.73 for the conventional patients.

This led to a mean excess BMI loss of 95.7% for the banded group, compared with 77.81% for the conventional group.

The banded group reduced their mean diastolic pressure from 84.78mmHg to 70.2mmHg, compared with a drop of 85.97mmHg to 82.01mmHg in the conventional group. The two groups’ systolic pressure dropped from 139.28mmHg to 105.9mmHg and 141.29mmHg to 129.5mmHg, respectively.

The reduction in blood pressure in the banded group took the patients out of prehypertension or stage 1 hypertension to within normal blood pressure levels.

Diabetic factors were comparable between the two groups: HbA1c dropped from 6.22% to 5.35% in the banded group and 6.49% to 5.51% in the conventional group, while glucose dropped from 120.52mg% to 87.25mg% and 120.08mg% to 82.03mg%, respectively.

While the banded operation had complications unique to the band, there was a reduction in incidents of malnutrition compared to the conventional group, meaning that there was a lower overall complication rate: 16 out of 83 patients (19.27%) suffered complications in the banded group, compared with 14 out of 60 patients (23%) in the conventional group.

In the banded group, two patients suffered from ring rupture and three patients required the removal of the ring. There were also two cases of gastritis, one case of oesophagitis, and three cases of recurrent vomiting (compared with two cases of recurrent vomiting in the conventional group).

Patients selected for the trial were aged 18-60, with a BMI between 40 and 50, and were sweet eaters or volume eaters. They were also required to have either one or two of the following comorbidities: hypertension, type 2 diabetes, hyperlipidemia, hyperuricemia, or degenerative diseases of the spine, hip, knee, or foot.

Follow-up for the study is continuing, and the two-year results presented at IFSO 2012 will be published in April 2013.

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